Multi centre audit An evaluation of the safe prescribing

and administration of Warfarin in Community Hospitals

Lelly Oboh, Consultant Pharmacist, Care of Older People East & South East NHS Specialist Pharmacy Services

23rd September 2014

East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast

Medicines Use and Safety

©East & South East England Specialist Pharmacy Services

S

P S

MUS Team: Winner: RPS Pharmaceutical Care award 2013; Finalist: HSJ Patient safety in primary care award 2013; Winner: UKCPA/Guild Conference Best Poster award 2013; Winner: UKCPA Pain award 2012;

Winner: UKCPA Respiratory award 2012

Overview

• Background and context

• Criteria and Justification

• Methodology

• Results and discussions

• Key points and recommendations

Background Part of a collaborative evaluation study to measure

the number and clinical significance of pharmacy contributions in community health services

Aim of audit

• To evaluate the safe prescribing and administration of warfarin in community hospitals

• To make recommendations around the use of warfarin which could be addressed locally and nationally

Why Warfarin? (1,2) • Well established for preventing thromboembolism in

AF, prosthetic valves, DVT, PE, TIA etc

• Most frequently prescribed oral anticoagulant in UK

• Commonly implicated in preventable harms, hospital admissions and claims in NHS Most significant ADR is haemorrhage

– Usually INR >5

– Those on long term therapy

– Risk highest in first 3 months of treatment

• National drivers

1. Baglin, T P et al. Recommendations from the British Committee for Standards in Haematology and National Patient Safety Agency. British Journal of Haematology, 136, 26–29 2. Emergency Hospitalizations for Adverse Drug Events in Older Americans. N Engl J Med 2011; 365:2002-2012

Problems with warfarin • Biological variation in drug handling sensitivity to

even small changes dosing must be individualised

• No. of people involved in care transfer of information, communication

• Regular blood monitoring disruption to lifestyle

• Under coagulation (haemorrhage) and over coagulation(thrombosis) ADR and fatalities

• Drug food interactions are common

• Renal excretion (problems in older people)

NPSA Alert 18 2007 Reasons for high incidents of harm*

1. Staff training and competencies inadequate 2. Poor documentation of reason and treatment plan at start

of therapy. 3. Co-prescribing and monitoring of interacting drugs not

considered. 4. Poor transfer of care & communication from hospital to GP 5. Insufficient support and monitoring in first 3 months and

for vulnerable groups. 6. Potential confusion due to different strength and

packaging 7. Inadequate audit of anticoagulant services and/or failure

to act on identified risks

*those particularly relevant to community hospital settings

NPSA Alert 18 2007 Actions that can make anticoagulant therapy safer

NHS and independent sector (by Mar 2008)

1. Properly trained staff

2. Review and / or update written procedures and clinical protocols safe practice

3. Annual Audit of anticoagulant services using BSH/NPSA safety indicators inform commissioning and performance mgt

4. Patients prescribed anticoagulants receive appropriate written & verbal information.

5. Promote safe practice for prescribers and pharmacists regularly monitor INR safe level before issuing or dispensing repeat prescriptions

6. Promote safe practice for co-prescribing interacting medicines

7. dental practitioners follow evidence-based guidelines.

8. Standardise the range of anticoagulant products used

9. Written safe practice procedures for administration in social care settings (incl.MCA).

Audit Criteria 1-6 Relate to having the right information to ensure safety

Criteria Justification

1. Clear indication for warfarin stated

in the patient notes

Warfarin is a high risk drug and there should be a clear

indication why the patient is on it- AF, mechanical heart

valves, DVT, PE

2. There is a Yellow (INR) book for the

patient

Yellow book should show the most current monitoring

information/dose to ensure safety

3. Target range for INR is stated in

the yellow book

Out of range: under and over coagulation can lead to ADRs

4. Duration of therapy OR stop date

is stated in the yellow book/patient

notes

To prevent unnecessary long term use. usually 6weeks to

6months or for life if CVS condition

5. Recommended date for next INR is

stated in the yellow book

Ensure regular monitoring is done

6. Date for next INR is overdue Ensure regular monitoring is done

Audit Criteria 7-12 Relate to information needed to ensure safe administration

Criteria Justification

7. Last INR is within the range stated in

the Yellow book

Out of range: under and over coagulation can lead

to ADRs

8. What is last recorded INR?

9. Dose on MAR/prescription chart is as

stated in Yellow book

Wrong dosing can lead to higher risks of ADRs

10. Dose given or reason for not given is

documented

Omitted drugs can lead to ADRs

11. Interacting drug started or stopped in

the last week

Interacting drugs can cause fluctuation in INR and

lead to ADRs. In some sensitive people a small

change in dose, adding or stopping interacting

drug, herbal supplements, food etc can lead to a

significant change in warfarin levels

12. If Yes to Q11, was INR done within 4-7

days of stopping or starting drug

Close monitoring is needed when interacting drugs

are co-prescribed

Audit Criteria 13-16 Relate to safe prescribing

Criteria Justification

13. Warfarin is prescribed by

milligrams (not number of

tablets)

To reduce the risks of giving the wrong dose

14. Least number of tablet

combination is administered

To reduce pill burden

15. Daily dosing only (not alternate

day dosing)

Alternate dosing increases risk of medicines error

16. Whole tablets only (not half

tablets)

Increases risk of medicines error

17. Patient suffered adverse effect

in last week e.g. bruising, nose

bleeds

ADR monitoring

Methodology and data collection

• Snapshot audit in any 2 week period (Nov 2013)

• Simple data collection form designed and piloted in 2 community hospital wards

• Slight amendments and final tool agreed

• Data collected as part of study patients identified as taking warfarin where selected to participate in audit

• One form completed per patient

Results

• 192 entries from 15 Trusts (23 Sites)

• 15 entries from prison setting excluded

• 177 entries analysed

Participating sites No.of entries %

Berkshire Healthcare NHS Foundation Trust (Prospect Park)- RWX 7 4%

Berkshire Healthcare NHS Foundation Trust (St Marks) - RWX 1 1%

Berkshire Healthcare NHS Foundation Trust (Upton) - RWX 5 3%

Berkshire Healthcare NHS Foundation Trust (West Berkshire) - RWX 4 2%

Berkshire Healthcare NHS Foundation Trust (Wokingham) - RWX 4 2%

Cambridgeshire Community Services NHS Trust - RYV 6 3%

CNWL Foundation Trust (Camden) - RV3 1 1%

CNWL Foundation Trust (Hillingdon) - RV3 1 1%

Ealing Hospital NHS Trust (Willesden) - RC3 3 2%

East Coast Community Healthcare (Northgate)- SE3 1 1%

East Coast Community Healthcare (Beccles) - SE3 1 1%

East Sussex Healthcare NHS Trust - RXC 19 11%

Epsom and St Helier University Hospitals NHS Trust - RVR 13 7%

Hounslow and Richmond Community Healthcare Trust - RY9 7 4%

Medway Community Healthcare - SE1 5 3%

NELFT - RAT 9 5%

Oxford Health NHS Foundation Trust RNU 64 36%

Oxleas NHS Foundation Trust - RPG 3 2%

Provide - SE2 5 3%

SEPT (Bedfordshire) - RWN 2 1%

Sussex Community Trust (B&H) 3 2%

Sussex Community Trust (Kleinwort) 1 1%

Sussex Community Trust (WSHT) 12 7%

TOTAL 177 100%

172, 97%

5, 3%

1. Clear indication for warfarin stated in the patient records (e.g. notes or yellow book)

Yes

No

48, 27%

129, 73%

2. There is a Yellow (INR) book for the patient?

Yes

No

*Results skewed as the Trusts with the highest number of entries answered “NO” to this question

40, 23%

14, 8%

123, 69%

3. Target range for INR is stated in the yellow book?

Yes

No

No Yellow book

• YES 23% vs 74% with yellow book in place • Inconsistencies in data about yellow book

50, 28%

20, 11% 107, 61%

4. Duration of therapy OR stop date is stated in the yellow book/patient notes?

Yes

No

No Yellow book

• YES 28% vs 71% with yellow book in place • Inconsistencies with data about yellow book

37, 21%

15, 8% 125, 71%

5. Recommended date for next INR is stated in the

yellow book?

Yes

No

No Yellow book

• YES 21% vs 71% with yellow book in place • Inconsistencies with data about yellow book

24, 65%

13, 35%

6. Date for next INR is overdue?

Yes

No

40, 23%

22, 12% 115, 65%

7. Last INR is within the range stated in the Yellow book?

Yes

No

No Yellow Book

• YES 23% vs 74% with yellow book in place • Inconsistencies with data

8. What is last recorded INR?

Last INR No of entries (177)

INR 0.9 or less 0

1.0 - 5.0 169

5.1 and above 2

Not recorded 6 (2 new starters, 4 not found)

• YES 16% vs 68% with yellow book in place • Inconsistencies with data

9. Dose on MAR /prescription chart is as stated in Yellow book?

26, 16%

12, 8%

121, 76%

Yes

No

No Yellow Book

158, 89%

19, 11%

10. Dose given or reason for not given is documented?

Yes

No

17, 10%

160, 90%

11. Interacting drug started or stopped in the last week?

Yes

No

16, 94%

1, 6%

12. If Yes to question 11, was INR done within 4-7 days of stopping or

starting drug?

Yes

No

174, 98%

3, 2%

13. Warfarin is prescribed by milligrams (not number of tablets)?

Yes

No

175, 99%

2, 1%

14. Least number of tablet combination is administered?

Yes

No

169, 95%

8, 5%

15. Daily dosing only (not alternate day dosing)?

Yes

No

171, 97%

6, 3%

16. Whole tablets only (not half tablets)?

Yes

No

6, 3% 0, 0%

171, 97%

17. Patient suffered adverse effect in last week e.g. bruising, nose bleeds?

Yes

No

Not recorded

Entries recording adverse effects did not correlate with INR being out of range, > 5 or below 1

Results: data limitations

• No yellow book in 105-129 cases (59-73%)

• “Not recorded in yellow book” is not same as “not recorded”

• Entries too few to analyse by Trust (bar Oxford)

• Inconsistencies in data entry within same organisations

• Not the full range of NPSA/BSH indicators

• ?? Self administration not considered

Summary of results CRITERIA. Records show….. Baseline

1 Clear indication for warfarin stated in the patient notes 97%

2 There is a Yellow (INR) book for the patient 27%

3 Target range for INR is stated in the yellow book 23%(74%)

4 Duration of therapy OR stop date is stated in the yellow book/patient notes 28% (71%)

5 Recommended date for next INR is stated in the yellow book 21% (71%)

6 Date for next INR is overdue 35%

7 Last INR is within the range stated in the Yellow book 23% (74%)

8 What is the last INR? -

9 Dose on MAR/prescription chart is as stated in Yellow book 16% (68%)

10 Dose given or reason for not given is documented 89%

11 Interacting drug started or stopped in the last week 10%

12 If Yes to Q11, was INR done within 4-7 days of stopping or starting drug 94%

13 Warfarin is prescribed by milligrams (not number of tablets) 98%

14 Least number of tablet combination is administered 99%

15 Daily dosing only (not alternate day dosing) 95%

16 Whole tablets only (not half tablets) 97%

17 Patient suffered adverse effect in last week e.g. bruising, nose bleeds 3%

Key points Positive

• Indication for warfarin stated

• Safe choice of products

• Monitoring of interacting drugs

Key points Improvements needed

• Appropriate records to ensure safe use and administration – Target

– Duration of treatment

– Date of next INR and action taken

– Previous INR Within range

– Dose required is given on MAR chart

• Recording reasons for omitted drugs

Conclusion and recommendations CONCLUSION • Patterns were generally similar across the different Trusts

Interpretation of data and recommendations can be applied across the patch

RECOMENDATIONS • Review local protocols/guidelines

– Ensure INR monitoring and dosing information is recorded in an easily accessible place (preferably the Yellow book)

– Reinforce need to record reasons omitted doses – Ensure appropriate action is taken in light of INR results

• Re-audit after 6-12months (incl. Standards) • Feed back results within organisation to improve care